Sopavi

PATIENT LEAFLET: INFORMATION FOR THE USER

SOPAVI 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets

Atorvastatin
Generic medicine
Please read this leaflet carefully before using this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you. Never give it to others, even if their symptoms are the same as yours, as it could be dangerous.
• If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

1. What SOPAVI is and what it is used for
2. Before you take SOPAVI
3. How to take SOPAVI
4. Possible side effects
5. How to store SOPAVI
6. Further information

1. WHAT SOPAVI IS AND WHAT IT IS USED FOR

SOPAVI belongs to a group of medicines called statins, which are lipid-regulating drugs (fats).
SOPAVI is used to reduce lipids known as cholesterol and triglycerides in the blood when a low-fat diet and lifestyle changes without other measures have failed. If you are at increased risk of heart disease, SOPAVI may also be used to reduce this risk, even if your cholesterol levels are normal. During treatment, a standard cholesterol-lowering diet must continue.

2. BEFORE USING SOPAVI

Do not use SOPAVI

• if you are allergic (hypersensitive) to atorvastatin or to medicines similar to those used to lower blood fats, or to any of the excipients of this medicine – see section 6 for details.
• if you have or have had any liver disease
• if you have had unexplained abnormal blood test results for liver function
• if you are a woman of childbearing age who is not using adequate contraception
• if you are pregnant or trying to become pregnant
• if you are breastfeeding
• if you are taking the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C

Take special care with SOPAVI
SOPAVI may not be suitable for you for the following reasons:

• if you have previously had a stroke with bleeding into the brain or small pockets of fluid in the brain following prior strokes
• if you have kidney problems
• if your thyroid gland is underactive (hypothyroidism)
• if you suffer from recurrent or unexplained muscle pain, or if you or a family member has had muscle disorders
• if you have previously experienced muscle problems during treatment with other lipid-lowering medicines (e.g. other drugs known as "statins" or "fibrates")
• if you have severe respiratory insufficiency
• if you regularly consume large amounts of alcohol
• if you have a history of liver disease
• if you are over 70 years of age
• if you have or have had myasthenia gravis (a disease characterized by generalized muscle weakness, sometimes including muscles used for breathing) or ocular myasthenia (a disease causing weakness of eye muscles), since statins may occasionally worsen myasthenia or trigger its onset (see section 4).

Check with your doctor or pharmacist before taking SOPAVI

• if you have severe respiratory insufficiency. If any of the above conditions apply to you, your doctor may need to perform blood tests before and possibly during your treatment with SOPAVI to assess the risk of muscle-related side effects. The risk of muscle-related side effects, such as rhabdomyolysis, is known to increase when certain medicines are taken concomitantly (see section 2 "Taking SOPAVI with other medicines").

In addition, inform your doctor or pharmacist if you experience persistent muscle weakness. Further
examinations and treatments may be required to diagnose and manage this condition.
During treatment with this medicine, your doctor will closely monitor whether you have diabetes or are at risk of developing diabetes. You are at risk of developing diabetes if you have high levels of sugar and fats in your blood, if you are overweight, and if you have high blood pressure.

Taking SOPAVI with other medicines
Some medicines may alter the effect of SOPAVI, or their effects may be altered by SOPAVI. This type of interaction may make one or both medicines less effective. Conversely, it could also increase the risk or severity of adverse effects, including a serious condition of muscle breakdown known as rhabdomyolysis, described in section 4.

• Medicines used to modify the activity of the immune system, e.g. cyclosporine
• Certain antibiotics and antifungal medicines, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid
• Other medicines used to regulate lipid levels, e.g. gemfibrozil, other fibrates, colestipol
• Certain calcium channel blockers used for angina or high blood pressure, e.g. amlodipine, diltiazem; medicines used to regulate heart rhythm, e.g. digoxin, verapamil, amiodarone
• Medicines used in the treatment of HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, etc.
  • Certain medicines used in the treatment of hepatitis C, e.g. telaprevir, boceprevir, and the combination of elbasvir/grazoprevir
• Other medicines known to interact with SOPAVI include ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant for epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazone (a painkiller), colchicine (used to treat gout), and antacids (indigestion remedies containing aluminium or magnesium)
• over-the-counter medicines: St. John’s wort

Inform your doctor or pharmacist if you are taking or have recently taken any other medicines,
including those not requiring a prescription.

Taking SOPAVI with food and drinks
See section 3 for instructions on how to take SOPAVI. Please note the following:
Grapefruit juice
Do not drink more than one or two small glasses of grapefruit juice per day, as large quantities of grapefruit juice may alter the effects of SOPAVI.
Alcohol
Avoid drinking alcohol while taking this medicine. See section 2 Take special care with SOPAVI for further information.

Pregnancy and breastfeeding
Do not take SOPAVI if you are pregnant or planning to become pregnant.
Do not take SOPAVI if you are a woman who could become pregnant and are not using reliable contraception.
Do not take SOPAVI if you are breastfeeding.
The safety of SOPAVI during pregnancy and breastfeeding has not been established. Please consult your doctor or pharmacist before taking any medicine during pregnancy.

Driving and using machines
Normally this medicine does not affect your ability to drive or use machinery. However, do not drive if this medicine affects your ability to drive. Do not use any tools or machinery if your ability to use them is affected by this medicine.

3. HOW TO TAKE SOPAVI

Before starting treatment, your doctor will put you on a cholesterol-lowering diet. You must follow this
diet during treatment with SOPAVI.
The usual dose of SOPAVI is 10 mg once daily in adults and children above 10 years of age. This dose may be
increased by your doctor if necessary until the appropriate amount for you is reached. Your doctor will adjust
the dose at intervals of 4 weeks or more. The maximum dose of SOPAVI is 80 mg once daily for adults and
20 mg once daily for children.
SOPAVI tablets should be swallowed whole with a glass of water and may be taken at any time of day, with
or without food. However, try to take the tablet at the same time each day.
Always take SOPAVI exactly as your doctor has instructed. If you have any doubts, consult your doctor or
pharmacist.
The duration of treatment with SOPAVI will be determined by your doctor.
Ask your doctor if you think that the effect of SOPAVI is too strong or too weak.
If you take more SOPAVI than you should
If you accidentally take too many SOPAVI tablets (more than the usual daily dose), contact your doctor or
the nearest emergency department immediately.
If you forget to take SOPAVI
If you forget to take a dose, take the next dose at the scheduled time.
Do not take a double dose to make up for the missed dose.
If you stop taking SOPAVI
If you have any questions about using this medicine or if you wish to stop treatment, speak to your doctor or
pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, SOPAVI can cause side effects, although not everybody experiences them.
If you experience any of the following serious side effects, stop taking the tablets and
contact your doctor immediately or go to the nearest hospital emergency department.
Rare: affects 1 to 10 users in 10,000:

• severe allergic reaction causing swelling of the face, tongue and throat, which may cause severe breathing difficulties
• severe illness with extensive peeling and swelling of the skin, blisters on the skin, mouth, eyes, genitals and fever. Skin rash with reddish spots, particularly on the palms of the hands or soles of the feet, which may develop into blisters.
• Muscle weakness, tenderness, pain or tearing, especially if at the same time you feel unwell or have a high fever, which may be due to abnormal breakdown of muscles (rhabdomyolysis). Abnormal muscle breakdown does not always resolve, even after stopping atorvastatin, and may potentially be fatal and lead to kidney problems. Very rare: affects fewer than 1 user in 10,000:
• lupus-like syndrome (including skin rash, joint disorders and effects on blood cells)
• if you experience problems with unusual or unexpected bleeding or bruising, this may suggest a liver disorder. You should consult your doctor as soon as possible.

Other possible side effects with SOPAVI:
Common side effects (affecting 1 to 10 users in 100) include:

• nasal inflammation, sore throat, nosebleeds
• allergic reactions
• increased blood sugar levels (if you have diabetes, continue to monitor your blood sugar levels carefully), increased creatine kinase in blood
• headache
• nausea, constipation, gas, indigestion, diarrhea
• joint and muscle pain, back pain
• liver function test results may be abnormal

Uncommon side effects (affecting 1 to 10 users in 1,000) include:

• anorexia (loss of appetite), weight gain, decreased blood sugar levels (if you have diabetes, continue to monitor your blood sugar levels carefully)
• nightmares, insomnia
• dizziness, numbness or tingling in fingers and toes, reduced sensation to pain or touch, changes in taste perception, memory loss
• blurred vision
• ringing in the ears and/or head
• vomiting, belching, upper and lower abdominal pain, pancreatitis (inflammation of the pancreas causing stomach pain)
• hepatitis (inflammation of the liver)
• rash, skin eruptions and itching, hives, hair loss
• neck pain, muscle fatigue
• fatigue, feeling unwell, weakness, chest pain, swelling, especially of the ankles (edema), increased body temperature
• urine tests showing positive for white blood cells

Rare side effects (affecting 1 to 10 users in 10,000) include:

• vision disorders
• unexpected bleeding or bruising
• cholestasis (yellowing of the skin and whites of the eyes)
• tendon injury

Very rare side effects (affecting fewer than 1 user in 10,000) include:

• an allergic reaction – symptoms may include sudden shortness of breath and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue or throat, difficulty breathing, collapse
• hearing loss
• gynecomastia (breast enlargement in men and women) Side effects with unknown frequency: Myasthenia gravis (a condition causing generalized muscle weakness, including in some cases the muscles used for breathing). Ocular myasthenia (a condition causing weakness of the eye muscles).

Contact your doctor if you experience worsening weakness in arms or legs after periods of activity,
double vision or drooping eyelids, difficulty swallowing or shortness of breath.
Possible side effects reported with some statins (medicines of the same type):

• Sexual difficulties
• Depression
• Respiratory problems including persistent cough and/or shortness of breath or fever.
• Diabetes. This is more likely if you have high levels of sugar and fats in your blood, are overweight and have high blood pressure. Your doctor will monitor you during treatment with this medicine.

If any of the side effects worsen, or if you notice any side effects not listed in this leaflet,
inform your doctor or pharmacist.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your
doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of
this medicine.

5. HOW TO STORE SOPAVI

Keep SOPAVI out of the sight and reach of children.
This medicine does not require any special storage conditions.
The shelf life of the product after first opening the bottle is 100 days.
Do not use SOPAVI after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of the month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. OTHER INFORMATION

What SOPAVI contains

• The active substance is atorvastatin as atorvastatin calcium. Each film-coated tablet of 10 mg, 20 mg or 40 mg contains 10 mg, 20 mg or 40 mg of atorvastatin, respectively.
• The other excipients are:
  Tablet core: mannitol, microcrystalline cellulose, crospovidone, anhydrous sodium carbonate, povidone, methionine, magnesium stearate.

Coating: hypromellose 6 cP, titanium dioxide (E171), macrogol 6000, talc

Description of the appearance of SOPAVI and packaging contents
Film-coated tablets
10 mg: White, oval, biconvex film-coated tablet, 4.9 x 9.1 mm, imprinted with “10” on one side and “A” on the other
20 mg: White, oval, biconvex film-coated tablet, 6.2 x 11.5 mm, imprinted with “20” on one side and “A” on the other
40 mg: White, oval, biconvex film-coated tablet, 7.8 x 14.5 mm, imprinted with “40” on one side and “A” on the other

Packaging:
Blister packs:
SOPAVI 10 mg film-coated tablets: 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 100, 200 (10x20), 500 tablets.
SOPAVI 20 mg film-coated tablets: 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 100, 200 (10x20), 500 tablets.
SOPAVI 40 mg film-coated tablets: 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 100, 200 (10x20), 500 tablets.

Bottle pack:
SOPAVI 10 mg film-coated tablets: 10, 20, 30, 50, 100, 200 tablets.
SOPAVI 20 mg film-coated tablets: 10, 20, 30, 50, 100, 200 tablets.
SOPAVI 40 mg film-coated tablets: 10, 20, 30, 50, 100, 200 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Genetic S.p.A.
Via G. Della Monica, 26
84083 Castel San Giorgio (SA), Italy

For all packs:
Manufacturers
Actavis hf.
Reykjavíkurvegi 78
IS-220 Hafnarfjörður
Iceland
Actavis Ltd
BLB016 Bulebel Industrial Estate
Zejtun ZTN 3000
MALTA

For the following packs:
10 mg film-coated tablets – 30 tablets in AL/AL blister
20 mg film-coated tablets – 30 tablets in AL/AL blister
40 mg film-coated tablets – 30 tablets in AL/AL blister
Actavis hf.
Reykjavíkurvegi 78
IS-220 Hafnarfjörður
Iceland
Actavis Ltd
BLB016 Bulebel Industrial Estate
Zejtun ZTN 3000
MALTA
Genetic S.p.A.
Contrada Canfora – 84084 Fisciano (SA), Italy

This medicinal product is authorized in the European Economic Area Member States under the following names:
Italy: Sopavi

This Patient Information Leaflet was last approved on: